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New Animal Drugs for Use in Animal Feeds; Fenbendazole

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for use of a fenbendazole free choice, liquid Type C medicated feed in dairy and beef cattle for the removal and control of various internal parasites.

DATES:

This rule is effective October 8, 2008.

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FOR FURTHER INFORMATION CONTACT:

Donald A. Prater, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: donald.prater@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed a supplement to NADA 131-675 for SAFE-GUARD (fenbendazole) 20% Type A medicated article. The supplemental NADA provides for manufacture of a fenbendazole free choice, liquid Type C medicated feed for use in dairy and beef cattle for the removal and control of various internal parasites. The supplemental NADA is approved as of September 5, 2008, and the regulations are amended in 21 CFR 558.258 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The 3 years of exclusivity apply only to the use of fenbendazole liquid Type C medicated feed for the removal and control of lungworms (Dictyocaulus viviparus), one of the parasite species for which the supplement is approved.

FDA has determined under 21 CFR 25.33(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

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List of Subjects in 21 CFR Part 558

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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2. In § 558.258, in the table in paragraph (e)(1), in the “Indications for use” column, remove “round worms” and in its place add “roundworms”; and revise paragraph (e)(3) to read as follows:

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Fenbendazole.

(e) * * *

(3) Cattle.

Amount fenbendazoleIndications for useLimitationsSponsor
(i) 5 mg/kg body weight (2.27 mg/lb)Dairy and beef cattle: For the removal and control of: Lungworms (Dictyocaulus viviparus); Stomach worms: barberpole worms (Haemonchus contortus), brown stomach worms (Ostertagia ostertagi), small stomach worms (Trichostrongylus axei); Intestinal worms: hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia oncophora and C. punctata); Bankrupt worms (Trichostrongylus colubriformis); and Nodular worms (Oesophagostomum radiatum).Feed as the sole ration or as a top dress for one day. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.057926
(ii) [Reserved]
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(iii) Free-choice feeds—(A) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formulations:

Ingredient1PercentInternational Feed No.
(1) Free-choice, dry Type C feed:
  Salt (sodium chloride)59.006-04-152
  Monosodium phosphate31.166-04-288
  Dried cane molasses3.124-04-695
  Zinc sulfate0.766-05-556
  Copper sulfate0.456-01-720
  Fenbendazole 20% Type A article5.51n/a
(2) Free-choice, dry Type C feed:
  Salt (sodium chloride)35.936-04-152
  Dicalcium phosphate (18.5% P)32.446-00-080
  Calcium carbonate (38% Ca)15.936-01-069
  Magnesium oxide (56% Mg)10.146-02-756
  Zinc sulfate1.476-05-556
  Mineral oil1.008-03-123
  Dried cane molasses (46% sugars)0.984-04-695
  Potassium iodide0.016-03-759
  Fenbendazole 20% Type A article2.10n/a
(3) Free-choice, liquid Type C feed:
  Cane molasses280.9024-13-251
  Water9.36n/a
  Urea solution, 55%7.055-05-707
  Phosphoric acid 75% (feed grade)2.006-03-707
  Xantham gum0.208-15-818
  Trace minerals0.20n/a
  Vitamin premix0.01n/a
  Fenbendazole 20% Type A article0.278n/a
1 The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920).
2 The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to the industry standard of 79.5 brix.

(B) Indications for use. As in paragraph (e)(3)(i) of this section.

(C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 13 days following last treatment. For dairy cattle the milk discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

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Dated: September 29, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E8-23845 Filed 10-7-08; 8:45 am]

BILLING CODE 4160-01-S